Active ingredient
Disopyramide
8 finished FDA listings contain Disopyramide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DISOPYRAMIDE PHOSPHATE
- Dosage forms
- Capsule, Capsule, Gelatin Coated
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 100 mg/1 · 150 mg/1
- Brand names in FDA listings
- Norpace
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3541
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 017447 | PFIZER | 1977-09-01 | 4 |
| ANDA 070101 | TEVA | 1985-02-22 | 1 |
| ANDA 070102 | TEVA | 1985-02-22 | 1 |
| ANDA 070173 | DR REDDYS LABS SA | 1985-05-31 | 2 |
Official labeling on DailyMed
- NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED NORPACE CR (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC] · version 22 · 2026-08-25
- DISOPYRAMIDE PHOSPHATE CAPSULE, GELATIN COATED [MYLAN PHARMACEUTICALS INC.] · version 5 · 2026-03-19
- DISOPYRAMIDE PHOSPHATE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] · version 16 · 2025-03-26
- DISOPYRAMIDE PHOSPHATE CAPSULE [DR. REDDY'S LABRATORIES INC.] · version 1 · 2024-03-18
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.